FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
109825–109848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1994
IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES
K933353 · GCJ
Utah Pioneer Medical, Inc.
General & Plastic Surgery · 228d
Cleared Feb 22, 1994
ACUMED RADIUS ROD
K933361 · HSB
Acu Med, Inc.
Orthopedic · 228d
Cleared Feb 22, 1994
PD-PAK
K933619 · MLW
General Medical Mfg. Co.
Gastroenterology & Urology · 218d
Cleared Feb 22, 1994
LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE
K933633 · HJG
Gracefully Yours, Inc.
Ophthalmic · 210d
Cleared Feb 22, 1994
SUNGLASSES
K933819 · HQY
California Bazar
Ophthalmic · 202d
Cleared Feb 22, 1994
SARNS LOW JETTING AORTIC ARCH CANNULA
K934127 · DWF
3M Health Care, Sarns
Cardiovascular · 181d
Cleared Feb 22, 1994
TRUE/FLEX CLAVICLE RODS
K934148 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 181d
Cleared Feb 22, 1994
SURGICAL ACCESSORIES LOOPED WIRE
K934176 · JDQ
Surgical Accessories, Inc.
Orthopedic · 179d
Cleared Feb 22, 1994
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES
K934440 · JDL
Howmedica Corp.
Orthopedic · 231d
Cleared Feb 22, 1994
MED-GENESIS PATIENT LASER EYE SHIELD
K934459 · IWS
Med-Genesis, Inc.
Radiology · 165d
Cleared Feb 22, 1994
SPECTACLE FRAMES
K934466 · HQZ
Airess, Inc.
Ophthalmic · 165d
Cleared Feb 22, 1994
SURGICAL SAW BLADES
K934603 · GFA
American Medical Specialties, Inc.
General & Plastic Surgery · 151d
Cleared Feb 22, 1994
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · HKI
Canon USA, Inc.
Ophthalmic · 147d
Cleared Feb 22, 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · JEC
Howmedica Corp.
Orthopedic · 145d
Cleared Feb 22, 1994
CULTURESWAB TRANSPORT SYSTEM
K934894 · JTW
Difco Laboratories, Inc.
Microbiology · 140d
Cleared Feb 22, 1994
REFLEX ESP WITH FINGER SWITCHES
K935105 · GEI
Richard-Allan Medical
General & Plastic Surgery · 123d
Cleared Feb 22, 1994
SUNGLASSES (NON-PRESCRIPTION)
K935114 · HQY
Promising Enterprise CO , Ltd.
Ophthalmic · 120d
Cleared Feb 22, 1994
BAUER TEMNO COAXIAL NEEDLE
K935538 · GDF
Bauer Medical, Inc.
General & Plastic Surgery · 98d
Cleared Feb 22, 1994
MEDNEXT BUR
K935584 · EQJ
Mednext, Inc.
Ear, Nose, Throat · 96d
Cleared Feb 22, 1994
SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
K935654 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Feb 22, 1994
IRRIGATION TRAY
K935740 · LRO
Cush Medical Products
General & Plastic Surgery · 83d
Cleared Feb 22, 1994
NON-PRESCRIPTION SUNGLASSES
K935764 · HQY
Airess, Inc.
Ophthalmic · 165d
Cleared Feb 22, 1994
MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
K935858 · LRO
Mill-Rose Laboratory
General & Plastic Surgery · 76d
Cleared Feb 22, 1994
SPLASHMASTER PRESCRIPTION EYEWEAR
K935903 · HQY
Cabot Safety Corp.
Ophthalmic · 74d